财务报表相关 - 公司的功能货币为英镑，但财务报表以美元为单位进行报告[1] - 截至2024年3月31日、2023年3月31日和2022年3月31日的代表性汇率分别为1英镑兑1.2626美元、1.23472美元和1.313896美元[1] - 2024财年、2023财年和2022财年的合并财务报表数据来自经审计的合并财务报表[1] - 公司截至2024年3月31日的现金及现金等价物余额为827,000美元，营运资金为负5,883,000美元[2] - 公司没有重大的资产负债表外安排[135] - 公司截至2024年3月31日的合同义务主要为7千美元的经营租赁[137][138] 财务业绩 - 2024财年研发费用为8,244,000美元，2023财年为6,338,000美元，2022财年为1,609,000美元[2] - 2024财年一般及行政费用为7,506,000美元，2023财年为6,849,000美元，2022财年为4,608,000美元[2] - 2024财年、2023财年和2022财年的净亏损分别为16,825,000美元、13,272,000美元和5,431,000美元[2] - 2024财年经营活动现金流出为9,490,537美元，较2023财年增加1,795,295美元，主要是OK-101临床试验II期推进导致[130,132] 持续经营能力 - 公司的独立注册会计师对公司的持续经营能力提出了重大疑虑[4] - 公司预计未来将持续亏损，需要大量资金用于研发活动[4] - 公司目前现金储备无法支持未来可预见的运营和资本支出需求，存在持续经营能力的重大不确定性[133] - 公司计划通过股权融资和其他融资活动满足未来资金需求，但可能需要放弃部分知识产权和未来收益权[133] 产品开发和商业化 - 即使产品获批上市,公司仍可能无法成功商业化,存在诸多障碍[5] - 公司正在投资并将继续投资资源开发其他产品，如OK-201[19] - 公司依赖第三方供应、开发、制造和临床服务关系，这可能会限制公司的能力并对收入产生不利影响[20] - 公司产品的保险报销和覆盖可能受到限制或降低，这可能会对公司的盈利能力产生不利影响[20] 知识产权保护 - 公司可能无法获得、维护或执行产品的充分知识产权保护，这可能会导致来自其他第三方产品的额外竞争[21] - 公司可能无法防止其商业机密、专有知识和其他专有信息被泄露[22] - 公司产品可能会侵犯第三方的专利和其他知识产权，这可能会导致昂贵的诉讼[23] 人才管理 - 公司的快速增长可能会给管理层和资源带来重大压力[24] - 公司高度依赖关键管理人员，他们的离职可能会对业务产生不利影响[24] - 公司可能无法吸引和留住关键人才，这可能会影响其运营和增长[25] 外部环境风险 - COVID-19疫情对公司业务造成不利影响，未来新的疫情爆发可能会进一步影响公司业务[26] - 公司面临产品责任索赔的固有风险，可能会导致销量下降、声誉受损、临床试验参与者减少等不利影响[27] - 公司员工、承包商等可能存在违规行为,如不遵守监管标准,这可能会给公司带来监管处罚和声誉损害[28] - 英国脱欧可能会影响公司在英国和欧盟的监管审批和产品上市进程,增加不确定性[29,30] 监管合规 - 公司需要获得监管机构对生产工艺和设施的批准,任何延迟或中断都可能影响产品开发和商业化[31,32] - 如果竞争对手先获得孤儿药资格认定,可能会限制公司产品在一定期限内获批[32] - 即使获得孤儿药独占权,也可能无法有效保护产品免受竞争,因为不同药物可能获批治疗同一适应症[33] - 即使获得监管批准,产品仍需遵守持续的监管要求,如制造、标签、包装、广告等[34] - 如未能遵守相关监管要求,可能会受到警告信、禁令、罚款等处罚,并影响公司的商业化能力[34] - 即使在美国等主要市场获批,也可能无法在其他主要市场获得批准,需要满足各国不同的监管要求[35] - 公司可能会申请有条件上市授权,但需满足相关要求,如风险收益平衡正面、能提供完整临床数据等[36] - 美国医疗改革法案可能会对公司的业务和经营业绩产生负面影响,如限制报销、增加折扣等[37,38] 隐私和数据安全 - 公司受到严格的隐私法、法规和标准以及与数据隐私和安全相关的合同义务的约束[19,20] - 公司可能无法完全有效地确保个人信息的隐私和安全,这可能会导致违反隐私和安全法律,并可能面临重大民事和刑事处罚[19,20] - 公司必须投入大量资源来理解和遵守不断变化的数据保护规则,否则可能会受到政府施加的罚款和处罚,面临诉讼和声誉损害[19,20] 医疗法规合规 - 公司的国际运营受到反腐败法律(如英国《反贿赂法》和美国《反海外腐败法》)以及贸易管制法律的约束,违反这些法律可能会导致严重后果[19,20] - 公司与客户、医生和第三方付款人的关系将直接或间接地受到联邦和州医疗保健欺诈和滥用法律、虚假索赔法律等的约束[20,21] - 公司需要大量投入资

LONDON and NEW YORK, Aug. 06, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and anterior ocular segment diseases including neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA approved therapy, announced today the grant of a key European Patent entitled: "Compositions Comprising Chemerin ...

LONDON and NEW YORK, Aug. 06, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and anterior ocular segment diseases including neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA approved therapy, announced today the grant of a key European Patent entitled: "Compositions Comprising Chemerin ...

About this content About Ian Lyall Ian Lyall, a seasoned journalist and editor, brings over three decades of experience to his role as Managing Editor at Proactive. Overseeing Proactive's editorial and broadcast operations across six offices on three continents, Ian is responsible for quality control, editorial policy, and content production. He directs the creation of 50,000 pieces of real-time news, feature articles, and filmed interviews annually. Prior to Proactive, Ian helped lead the business outpu ...

About this content About Ian Lyall Ian Lyall, a seasoned journalist and editor, brings over three decades of experience to his role as Managing Editor at Proactive. Overseeing Proactive's editorial and broadcast operations across six offices on three continents, Ian is responsible for quality control, editorial policy, and content production. He directs the creation of 50,000 pieces of real-time news, feature articles, and filmed interviews annually. Prior to Proactive, Ian helped lead the business outpu ...

Encouraging 68% improvement in responder rate results from patients who achieved both the conjunctival staining “sign” and ocular pain “symptom” endpoints from the 240 patient Phase 2 Dry Eye Disease (DED) trial Conjunctival staining and ocular pain represent potential co-primary endpoints to be explored in future trials LONDON and NEW YORK, July 10, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatmen ...

Encouraging 68% improvement in responder rate results from patients who achieved both the conjunctival staining “sign” and ocular pain “symptom” endpoints from the 240 patient Phase 2 Dry Eye Disease (DED) trial Conjunctival staining and ocular pain represent potential co-primary endpoints to be explored in future trials LONDON and NEW YORK, July 10, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatmen ...

LONDON and NEW YORK, April 30, 2024 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (NASDAQ:OKYO), a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and anterior ocular segment diseases including neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA approved therapy, today announced an upcoming presentation of the OK-101 Phase 2 data for dry eye disease at the ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 August 2023 Commission File Number: 001-41386 OKYO Pharma LTD (Exact Name of Registrant as Specified in Its Charter) 9Floor 107 Cheapside London EC2V 6DN (Address of registrant’s principal executive office) Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ...